NDC 54973-3375-01 - 4 Kids Cold and Cough Nighttime

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54973-3375
Requested NDC
54973-3375-01
Package NDCs from labels
54973-3375-1, 54973-3375-2, 54973-3375-3, 54973-3375-01
Manufacturer
Hyland's Consumer Health Inc. | Hyland's Inc.
Effective date
2025-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Naturals Kids Cold & Cough NighttimeHyland's Consumer Health Inc. | Hyland's Inc.2025-02-06HUMAN OTC DRUG LABEL
Hyland's Naturals Kids Cold 'n Cough Combo PackHyland’s Inc. | Hyland's Inc.2023-09-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3375-14 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-14 Kids Cold and Cough Nighttime118 mL in 1 BOTTLE, PLASTICLIQUID11811
54973-3375-24 Kids Cold and Cough Nighttime5 mL in 1 PACKETLIQUID511
54973-3375-34 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-34 Kids Cold and Cough Nighttime148 mL in 1 BOTTLE, PLASTICLIQUID14811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33754 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S CONSUMER HEALTH INC.]11Current NDC, Legacy NDC, 5 package rows20250209_71e93027-33c9-6147-e053-2a95a90aaa09.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 97 of 163 · 3,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: 451W47IQ8X
Numbness HPACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ARNICA MONTANA, COFFEA CRUDA, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, PHOSPHORUS, PLUMBUM METALLICUMEnergique, Inc.0c4ba547-b4b4-41d0-8a6b-1141ff5f94532024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
unii: 492225Q21H
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.Energique, Inc.76c6b494-43d1-4508-bea4-4f9026b4a5fa2024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
Nut AntigensALMOND (NUT), CASHEW (NUT), BLACK WALNUT (NUT), PECAN (NUT), COCONUT, OLEUM OLEA EUROPAEA, CHESTNUT (NUT), WATER CHESTNUT (NUT), PINENUT (NUT), MACADAMIA (NUT), PISTACHIO (NUT), PEANUT (NUT), ENGLISH WALNUT (NUT), BRAZIL NUT (NUT), HAZELNUT (NUT), ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SULPHUR, CARYA ALBAEnergique, Inc.e95845f0-26d1-4190-bb45-e5f276a2bba42024-10-29WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
Pre/Post SurgetoneHYPERICUM PERFORATUM, RHUS TOX, STAPHYSAGRIA, SYMPHYTUM OFFICINALE, ARNICA MONTANA, PHOSPHORUS, CALENDULA OFFICINALISEnergique, Inc.8cbe3be1-e50c-4ad9-ab15-c696059f03a22024-10-29WarningsExact identifier
unii: 27YLU75U4W
Jointstat BBCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOXEnergique, Inc.f0da5560-8025-4c2c-afaf-6f5fb92f90e82024-10-28WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
LipostatCAPSICUM ANNUUM, FUCUS VESICULOSUS, BORAGE OFFICINALIS, LECITHIN, CALCAREA CARBONICA, FERRUM METALLICUM, KALI BICHROMICUM, KALI CARBONICA, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87309894-d054-4b2f-aeba-bccd25b45f542024-10-28WarningsExact identifier
unii: 70FD1KFU70
Lungex IIGINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b2024-10-28WarningsExact identifier
unii: 27YLU75U4W
unii: 2968PHW8QP
IMMUNOPARASTRAGALUS MEMBRANACEUS, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, MUCOSA NASALIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, LACHESIS MUTUS, PHOSPHORUS, PYROGENIUMEnergique, Inc.ac04961b-1614-49a2-92d8-28ba283fb7a62024-10-28WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
HypothalmuparARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEAEnergique, Inc.8b01e718-83b7-4f93-8fea-d0e37c7561852024-10-28WarningsExact identifier
unii: 27YLU75U4W
HistatoneALLIUM SATIVUM, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SOLIDAGO VIRGAUREAEnergique, Inc.309fe946-8639-4c17-a939-06bffe6caa2d2024-10-25WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
unii: PDC6A3C0OX
DERMATOME HPLYCOPODICUM CLAVATUM, MEZEREUM, NATRUM MURIATICUM,Energique, Inc.54a096ac-7ebe-4565-b1b0-0473de16e70c2024-10-24WarningsExact identifier
unii: 451W47IQ8X
CirculaparCACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSEnergique, Inc.5bc2bcd0-5687-462a-8701-37c904a2e2d02024-10-24WarningsExact identifier
unii: 27YLU75U4W
Bowel - Digestive CareBISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.Newton Laboratories, Inc.907f582f-c060-cc60-e053-2a95a90a6f222024-10-24WarningsExact identifier
unii: 27YLU75U4W
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Cold HPACONITUM NAPELLUS, ALLIUM CEPA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, MERCURIUS SOLUBILIS, NUX VOMICA, PULSATILLA (VULGARIS)Energique, Inc.d13b3de8-b1bc-41bd-a964-c3d8ba9f29fd2024-10-24WarningsExact identifier
unii: 492225Q21H
unii: I76KB35JEV
GastroparGENTIANA LUTEA, SAMBUCUS NIGRA, STOMACH (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.128b917d-2d92-4c41-bbc4-09f916b822a52024-10-24WarningsExact identifier
unii: 27YLU75U4W
GastrotoneGENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (PRATENSIS), BISMUTHUM SUBNITRICUMEnergique, Inc.3e93ca93-0c1e-4305-bf0f-efd44c30a9d32024-10-24WarningsExact identifier
unii: 27YLU75U4W
FATIGUE NOSODE EBASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODEEnergique, Inc.36d963cc-fd47-40ee-aa73-c2e7fcedf1922024-10-24WarningsExact identifier
unii: ZW3Z11D0JV

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.